Trial studying safety and effects for Hidradenitis Suppurativa
Official title Evaluate the Safety and Efficacy of Subcutaneous Siplizumab in the Treatment of Hidradenitis Suppurativa.
ClinicalTrials.gov ID: NCT06326476
What this study is testing
What is Siplizumab?
Siplizumab is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for hidradenitis suppurativa.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is to investigate the efficacy of siplizumab in the treatment of Hidradenitis Suppurativa.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or Female at least 18 years of age, and provide informed consent prior to study procedures.
- Have moderate to severe HS classified as Hurley stage II or III for at least 6 months refractory to conventional therapies with a total AN count of...
- Failed at least 1 course of oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for...
- Women of Childbearing potential must have a urine pregnancy test at screening, wk 0 and prior to administration of the study medication
- Women of childbearing potential must be willing to continue a highly effective method of birth control throughout the study (oral, injected or...
You likely can't join if
- Any other active skin disease that in the opinion of the investigator would interfere with the assessment of HS
- Have greater than 20 draining fistulas at screening or Day 1 prior to enrollment/randomization
- Receipt of non-biologic treatments for HS within 4 weeks prior to baseline other than antibiotics or hormonal therapy
- Receipt of biologic agents within 3 months prior to baseline
- Receipt of any other investigational product within 3 months prior to baseline
- Receipt of new oral antibiotics or hormonal therapy within 6 weeks prior to baseline.
See the full eligibility criteria
- Male or Female at least 18 years of age, and provide informed consent prior to study procedures.
- Have moderate to severe HS classified as Hurley stage II or III for at least 6 months refractory to conventional therapies with a total AN count of greater than or equal to 5 prior to enrollment/randomization
- Failed at least 1 course of oral antibiotics for treatment of HS (or demonstrated intolerance to, or had a contraindication to oral antibiotics for treatment of their HS).
- Women of Childbearing potential must have a urine pregnancy test at screening, wk 0 and prior to administration of the study medication
- Women of childbearing potential must be willing to continue a highly effective method of birth control throughout the study (oral, injected or implanted hormonal methods of contraception; placement of an intrauterine...
- Negative screening for tuberculosis (TB) (Quantiferon Gold, T-spot) within 3 months prior to screening
- If a positive history of latent tuberculosis:
- Currently receiving treatment for latent TB per standard of care
- Have documentation of having completed treatment within 5 years prior to baseline
- Agree not to have a live vaccination during the study.
- Any other active skin disease that in the opinion of the investigator would interfere with the assessment of HS
- Have greater than 20 draining fistulas at screening or Day 1 prior to enrollment/randomization
- Receipt of non-biologic treatments for HS within 4 weeks prior to baseline other than antibiotics or hormonal therapy
- Receipt of biologic agents within 3 months prior to baseline
- Receipt of any other investigational product within 3 months prior to baseline
- Receipt of new oral antibiotics or hormonal therapy within 6 weeks prior to baseline.
- people may be included if they are on steady dose of doxycycline or tetracycline antibiotics only for at least 6 weeks prior to baseline visit and may not change or discontinue dose during course of study.
- Receipt of intralesional kenalog injections within 2 weeks prior to baseline
- Any uncontrolled diagnosis or condition that in the opinion of the investigator will interfere with the assessments or the study.
- Currently has a malignancy or a history of a malignancy within 5 years before screen (except successfully treated non-melanoma skin cancer or cervical carcinoma in situ)
- History of an ongoing, chronic or recurrent infectious disease
- Are currently pregnant, breastfeeding, or planning to get pregnant during the study.
- Previous hypersensitivity reaction to siplizumab or to any of the components
- Known infection with HIV, hepatitis B or hepatitis C at screening or randomization. Patients who are Hepatitis B Core antibody and/or Hep B Surface Antigen positive will be excluded from this study. Patients who are...
- Underlying condition (including, but not limited to metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal) which in the opinion of the investigator...
- Any of the following laboratory abnormalities within 30 days of enrollment:
- White blood count (WBC) \< 3 x 103/μL;,
- CD4+ count below the lower limit of normal,
- Platelet count \< 150,000 /μL,
- Hemoglobin \< 10 g/dL,
- ALT ≥ 2x upper limit of normal (ULN) or
- AST ≥ 2x ULN
- Serum creatinine \>1.5x ULN in adults.
- Positive molecular testing of SARS-CoV-2
- ALC less than 800 lymphocytes/mm3
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.